(91 days)
POLARSHEATH Steerable Sheath 12F: The POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart.
POLARMAP Circular Mapping Catheter: The POLARMAP Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
POLARMAP EP Electrical Cable: The EP Electrical Cable is designed for use with the POLARMAP Mapping Catheter and the hospital EP recording system. The EP Electrical Cable connects the POLARMAP Mapping Catheter to the hospital EP recording system. Use of the EP Electrical Cable is optional.
SMARTFREEZE ETS Cables: The Esophageal Temperature Sensor (ETS) Cable (model M004CRBS6310 or M004CRBS6320) is designed for use with the SMARTFREEZE Console and a general purpose series 400 temperature sensor. The ETS Cable is used to connect a general purpose series 400 temperature sensor to the ICB. Use of the ETS Cable is optional. The ETS Cable (CIRCA) (model M004CRBS6340) is designed for use with the SMARTFREEZE Console and the CIRCA S-CATH™ Esophageal Temperature Probe. The ETS Cable (CIRCA) is used to connect the CIRCA S-CATH™ Esophageal Temperature Probe to the ICB (Model M004CRBS4130 only). Use of the ETS Cable (CIRCA) is optional. NOTE: The role of esophageal temperature monitoring using this device in reducing the risk of cardiac cryoablation-related esophageal injury has not been established. The performance of the SMARTFREEZE ETS Cables and compatible temperature probe in detecting esophageal temperature changes as a result of energy delivery during cardiac cryoablation procedures has not been evaluated.
SMARTFREEZE Pressure Sensor Cable: The Pressure Sensor Cable is designed for use with the SMARTFREEZE Console and the cryoablation balloon catheter. The Pressure Sensor Cable is used to connect an intravascular pressure transducer to the ICB to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion. Use of the Pressure Sensor Cable is optional.
POLARSHEATH™ Steerable Sheath 12F: Single-use, steerable percutaneous introducer sheath designed for additional maneuverability of diagnostic and therapeutic catheters that are advanced through the POLARSHEATH™ Sheath and into cardiac chambers.
POLARMAP™ Circular Mapping Catheter: Single-use, multi-electrode catheter designed to record intracardiac electrograms and provide pacing stimulation during electrophysiology procedures.
POLARMAP™ EP Electrical Cable: Single-use electrical cable that connects the POLARMAP™ mapping catheter to the hospital EP recording system.
SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional).
SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional).
SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable: Re-usable cables used to connect a temperature probe to the Inter Connection Box (ICB); used for continuous temperature monitoring during ablation procedures (optional).
SMARTFREEZE™ Pressure Sensor Cable: Re-usable cable that connects an intravascular pressure transducer to the ICB. The pressure sensor is used to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion.
The provided text is a 510(k) summary for medical devices and does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document describes several medical devices:
- POLARSHEATH™ Steerable Sheath 12F
- POLARMAP™ Circular Mapping Catheter
- POLARMAP™ EP Electrical Cable
- SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables (various models)
- SMARTFREEZE™ Pressure Sensor Cable
These devices are hardware components used in cardiology procedures. The document establishes substantial equivalence to predicate devices based on technological characteristics and non-clinical performance testing. It does not refer to any AI/ML components or studies related to AI device performance.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2023
Boston Scientific Corporation Derek Charchuk Senior Regulatory Affairs Specialist 4100 Hamline Avenue North St. Paul, Minnesota 55112-5798
Re: K223824
Trade/Device Name: POLARSHEATH™ Steerable Sheath 12F, POLARMAP™ Circular Mapping Catheter, POLARMAPIM EP Electrical Cable, SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables (SMARTFREEZETM ETS Cable. SMARTFREEZE™ 16 PIN ETS Cable, SMARTFREEZE™ CIRCA ETS Cable), SMARTFREEZE™ Pressure Sensor Cable Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA, DRF Dated: December 20, 2022 Received: December 21, 2022
Dear Derek Charchuk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
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Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology. Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K223824
Device Name
POLARSHEATH™ Steerable Sheath 12F, POLARMAP™ Circular Mapping Catheter, POLARMAP™ EP Electrical Cable, SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables (SMARTFREEZE™ ETS Cable, SMARTFREEZE™ 16 PIN ETS Cable, SMARTFREEZE™ CIRCA ETS Cable), SMARTFREEZE™ Pressure Sensor Cable
Indications for Use (Describe)
POLARSHEATH Steerable Sheath 12F:
The POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart.
POLARMAP Circular Mapping Catheter:
The POLARMAP Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
POLARMAP EP Electrical Cable:
The EP Electrical Cable is designed for use with the POLARMAP Mapping Catheter and the hospital EP recording system. The EP Electrical Cable connects the POLARMAP Mapping Catheter to the hospital EP recording system. Use of the EP Electrical Cable is optional.
SMARTFREEZE ETS Cables:
The Esophageal Temperature Sensor (ETS) Cable (model M004CRBS6320) is designed for use with the SMARTFREEZE Console and a general purpose series 400 temperature sensor. The ETS Cable is used to connect a general purpose series 400 temperature sensor to the ICB. Use of the ETS Cable is optional.
The ETS Cable (CIRCA) (model M004CRBS6340) is designed for use with the SMARTFREEZE Console and the CIRCA S-CATH™ Esophageal Temperature Probe. The ETS Cable (CIRCA) is used to connect the CIRCA S-CATH™ Esophageal Temperature Probe to the ICB (Model M004CRBS4130 only). Use of the ETS Cable (CIRCA) is optional.
NOTE: The role of esophageal temperature monitoring using the risk of cardiac cryoablationrelated esophageal injury has not been established. The performance of the SMARTFREEZE ETS Cables and compatible temperature probe in detecting esophageal temperature changes as a result of energy delivery during cardiac cryoablation procedures has not been evaluated.
SMARTFREEZE Pressure Sensor Cable:
The Pressure Sensor Cable is designed for use with the SMARTFREEZE Console and the cryoablation balloon catheter. The Pressure Sensor Cable is used to connect an intravascular pressure transducer to the ICB to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion. Use of the Pressure Sensor Cable is optional.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY
510(k) Summary in Compliance with 21 CFR 807.92
I. SUBMITTER INFORMATION
Submitter Name: Boston Scientific Corporation
Submitter Address: 4100 Hamline Avenue North St. Paul, Minnesota USA 55112-5798
- Contact #1: Derek Charchuk Senior Regulatory Affairs Specialist Phone: (905) 696-1913 Email: derek.charchuk@bsci.com
- Contact #2: Jim Johnson Senior Regulatory Affairs Specialist Phone: (651) 582-5561 Email: jim.johnson(@bsci.com
Date Prepared: 19-December-2022
II. DEVICE INFORMATION
Generic Name: Sheath, Mapping Catheter, EP Electrical Cable, Temperature Sensor Cable, Pressure Sensor Cable
Trade Name: POLARSHEATH™ Steerable Sheath 12F
POLARMAP™ Circular Mapping Catheter
POLARMAP™ EP Electrical Cable
SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables:
- SMARTFREEZE™ ETS Cable .
- SMARTFREEZE™ 16 PIN ETS Cable ●
- . SMARTFREEZE™ CIRCA ETS Cable
SMARTFREEZE™ Pressure Sensor Cable
Product Codes:
DRA: POLARSHEATH™ Steerable Sheath 12F
DRF: POLARMAP™ Circular Mapping Catheter
POLARMAP™ EP Electrical Cable SMARTFREEZE™ Esophageal ETS Cables
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Traditional 510(k) submission POLARSHEATH Steerable Sheath 12F, POLARMAP™ Circular Mapping Catheter, POLARMAP™ EP Electrical Cable, SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables, and SMARTFREEZE™ Pressure Sensor Cable
SMARTFREEZE™ Pressure Sensor Cable
Device Class: Class II
Review Panel: Cardiovascular (DRA & DRF)
Classification Regulations:
(21 CFR 870.1280): POLARSHEATH™ Steerable Sheath 12F
(21 CFR 870.1220): POLARMAPTM Circular Mapping Catheter POLARMAP™ EP Electrical Cable SMARTFREEZE™ ETS Cables SMARTFREEZE™ Pressure Sensor Cable
III. PREDICATE DEVICE INFORMATION
Predicate Device #1: Flexcath Advance Steerable Sheath (12 French)
Manufacturer: Medtronic Cryocath LP 510(k) #: K123591 FDA Clearance Date: 27 December 2012 Product Code: DRA Predicate Device for: POLARSHEATH™ Steerable Sheath 12F
Predicate Device #2: Achieve Advance Mapping Catheter
Manufacturer: Medtronic Inc. 510(k) #: K162892 FDA Clearance Date: 15 November 2016 Product Code: DRF Predicate Device for: POLARMAP™ Circular Mapping Catheter, POLARMAP™ EP Electrical Cable, SMARTFREEZE™ Esophageal ETS Cables, and SMARTFREEZE™ Pressure Sensor Cable
Reference Device: CIRCA S-CATH M Esophageal Temperature Probe and Temperature Monitoring System
Manufacturer: CIRCA Scientific, LLC 510(k) #: K200943 FDA Clearance Date: 17 December 2021 Product Code: FLL, IKD Reference Device for: SMARTFREEZE™ Esophageal ETS Cables
IV. INDICATIONS FOR USE
POLARSHEATH™ Steerable Sheath 12F: The POLARSHEATH steerable sheath is indicated for percutaneous catheter introduction into the vasculature and into the chambers of the heart.
POLARMAP™ Circular Mapping Catheter: The POLARMAP Catheter is indicated for electrophysiological mapping (recording or stimulating only) of the cardiac structures of the heart.
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Traditional 510(k) submission POLARSHEATH™ Steerable Sheath 12F, POLARMAP™ Circular Mapping Catheter, POLARMAP™ EP Electrical Cable, SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables, and SMARTFREEZE™ Pressure Sensor Cable
POLARMAP™ EP Electrical Cable: The EP Electrical Cable is designed for use with the POLARMAP Mapping Catheter and the hospital EP recording system. The EP Electrical Cable connects the POLARMAP Mapping Catheter to the hospital EP recording system. Use of the EP Electrical Cable is optional.
SMARTFREEZE™ ETS Cables: The Esophageal Temperature Sensor (ETS) Cable (model M004CRBS6310 or M004CRBS6320) is designed for use with the SMARTFREEZE Console and a general purpose series 400 temperature sensor. The ETS Cable is used to connect a general purpose series 400 temperature sensor to the ICB. Use of the ETS Cable is optional.
The ETS Cable (CIRCA) (model M004CRBS6340) is designed for use with the SMARTFREEZE Console and the CIRCA S-CATH™ Esophageal Temperature Probe. The ETS Cable (CIRCA) is used to connect the CIRCA S-CATH™ Esophageal Temperature Probe to the ICB (Model M004CRBS4130 only). Use of the ETS Cable (CIRCA) is optional.
NOTE: The role of esophageal temperature monitoring using this device in reducing the risk of cardiac cryoablation-related esophageal injury has not been established. The performance of the SMARTFREEZE ETS Cables and compatible temperature probe in detecting esophageal temperature changes as a result of energy delivery during cardiac cryoablation procedures has not been evaluated.
SMARTFREEZE™ Pressure Sensor Cable: The Pressure Sensor Cable is designed for use with the SMARTFREEZE Console and the cryoablation balloon catheter. The Pressure Sensor Cable is used to connect an intravascular pressure transducer to the ICB to measure the ventricular pressure during ablation procedures to aid in determining vein occlusion. Use of the Pressure Sensor Cable is optional.
V. DEVICE DESCRIPTION
The subject devices are described below.
| Device | UPN/Model | Description |
|---|---|---|
| POLARSHEATH™Steerable Sheath 12F | M004CRBS3150 | Single-use, steerable percutaneous introducer sheath designedfor additional maneuverability of diagnostic and therapeuticcatheters that are advanced through the POLARSHEATH™Sheath and into cardiac chambers. |
| POLARMAP™ CircularMapping Catheter | M004CRBS7210 | Single-use, multi-electrode catheter designed to recordintracardiac electrograms and provide pacing stimulation duringelectrophysiology procedures. |
| POLARMAP™ EPElectrical Cable | M004CRBS62000 | Single-use electrical cable that connects the POLARMAP™mapping catheter to the hospital EP recording system. |
| SMARTFREEZE™Esophageal TemperatureSensor (ETS) Cable | M004CRBS6310 | Re-usable cables used to connect a temperature probe to theInter Connection Box (ICB); used for continuous temperaturemonitoring during ablation procedures (optional). |
| SMARTFREEZE™ 16 PINEsophageal TemperatureSensor (ETS) Cable | M004CRBS6320 | Re-usable cables used to connect a temperature probe to theInter Connection Box (ICB); used for continuous temperaturemonitoring during ablation procedures (optional). |
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Traditional 510(k) submission POLARSHEATH™ Steerable Sheath 12F, POLARMAP™ Circular Mapping Catheter, POLARMAP™ EP Electrical Cable, SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables, and SMARTFREEZE™ Pressure Sensor Cable
| SMARTFREEZE TM CIRCAEsophageal TemperatureSensor (ETS) Cable | M004CRBS6340 | |
|---|---|---|
| SMARTFREEZE TM PressureSensor Cable | M004CRBS6600 | Re-usable cable that connects an intravascular pressuretransducer to the ICB. The pressure sensor is used to measurethe ventricular pressure during ablation procedures to aid indetermining vein occlusion. |
VI. SUBSTANTIAL EQUIVALENCE & COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Comparison of Subject POLARSHEATH™ Steerable Sheath 12F versus Predicate Flexcath Advance Steerable Sheath 12F (Medtronic)
| Characteristic | Predicate Device (K123591)Flexcath Advance Steerable Sheath 12F(Medtronic Cryocath LP) | Subject DevicePOLARSHEATHTM Steerable Sheath 12F(Boston Scientific Corporation) | |
|---|---|---|---|
| Indications forUse | The FlexCath Advance SteerableSheath is intended for percutaneouscatheter introduction into thevasculature and into the chambers ofthe heart. | The POLARSHEATHTM steerable sheathis indicated for percutaneous catheterintroduction into the vasculature and intothe chambers of the heart. | |
| Sheath UsableLength | 65cm | 68cm | |
| Dilator OverallLength | 87cm | 87cm | |
| GuidewireCompatibility | 0.81mm and 0.89mm | 0.81mm and 0.89mm | |
| RadiopaqueMarkers | Yes | Yes | |
| Distal End | Unidirectional deflection curve | Unidirectional deflection curve | |
| Shaft Design | Deflectable shaft with single lumen | Deflectable shaft with single lumen | |
| HemostasisValve | Yes | Yes | |
| CompatibleCatheter Size | Facilitates use with catheters up to10.5F in diameter | Facilitates use with catheters up to 11.8Fin diameter | |
| Materials | Pebax with stainless steel braid andPTFE linerSilicone RubberPolycarbonatePolyethylene | Pebax with stainless steel braid and PTFElinerSilicone RubberPolycarbonatePolyethylene | |
| Packaging | Tyvek/nylon polyethylene pouch | Tyvek/nylon polyethylene pouch |
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Traditional 510(k) submission
POLARSHEATH™ Steerable Sheath 12F, POLARMAP™ Circular Mapping Catheter, POLARMAP™ EP Electrical Cable, SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables, and SMARTFREEZE™ Pressure Sensor Cable
| Characteristic | Predicate Device (K123591)Flexcath Advance Steerable Sheath 12F(Medtronic Cryocath LP) | Subject DevicePOLARSHEATHTM Steerable Sheath 12F(Boston Scientific Corporation) |
|---|---|---|
| Sterilization | Provided sterile (Ethylene Oxide) | Provided sterile (Ethylene Oxide) |
| Single Use orReusable | Single use | Single use |
Comparison of Subject POLARMAP™ Circular Mapping Catheter versus Predicate Achieve Advance Mapping Catheter (Medtronic)
| Characteristic | Predicate Device (K162892)Achieve Advance Mapping Catheter(Medtronic, Inc.) | Subject DevicePOLARMAP™ Circular Mapping Catheter(Boston Scientific Corporation) |
|---|---|---|
| Indications for Use | The Achieve Advance mappingcatheter is indicated for multipleelectrode electrophysiologicalmapping of the cardiac structuresof the heart, i.e. recording orstimulation only. The AchieveAdvance mapping catheter isdesigned to obtain electrogramsin the atrial regions of the heart. | The POLARMAP Catheter is indicatedfor electrophysiological mapping(recording or stimulating only) of thecardiac structures of the heart. |
| Shaft Size | 3.3F (1.10mm) | 3.3F (1.10mm) |
| Effective Length | 146 cm | 149 cm |
| Ring ElectrodeWidth | 1 mm | 1 mm |
| Loop Diameter | 20 mm(15mm and 25 mm also) | 20 mm |
| Number of RingElectrodes | 8 (20 mm loop diameterconfiguration) | 8 |
| Distal End Shape | Circular Loop | Circular Loop |
| Steering | Non-steerable | Non-steerable |
| Materials | Pebax (distal body)Polyimide (proximal)Nitinol insulated with PET | Pebax (distal shaft)Stainless steel (hypotube)Nitinol insulated with PET |
| Packaging | Individually packaged(box) | Individually packaged (carton) |
| Sterilization | Provided sterile (Ethylene Oxide) | Provided sterile (Ethylene Oxide) |
| Single Use orReusable | Single use | Single use |
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VII. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING
The non-clinical performance testing included in this 510(k) application provides evidence that the subject devices conform to user needs and intended use and are thus substantially equivalent to the predicates previously cleared under K123591 and K162892. No new safety or effectiveness issues were raised during device performance testing. The following test data is provided in this 510(k) application:
- Sterilization validation and EO residual assessment for the sterile POLARSHEATH™ Steerable . Sheath 12F, POLARMAP™ Circular Mapping Catheter, and POLARMAP™ EP Electrical Cable
- . Biocompatibility assessment and testing for the patient-contacting components of POLARSHEATH™ Steerable Sheath 12F and POLARMAP™ Circular Mapping Catheter devices
- . Performance Testing per IEC 60601-1: Medical electrical equipment - Part 1 and IEC 60601-1-2: Medical electrical equipment Part 1-2
- . Design verification testing of the devices and device packaging, demonstrating that the devices (and device packaging, if required/applicable) meet their design input requirements as per the product and/or packaging specifications Design verification testing at nominal (T=0) timepoint
- . Design verification testing at accelerated and/or real-time aging timepoints for devices with a labeled shelf life:
- T=12 months for POLARSHEATH™ Steerable Sheath 12F I
- 트 T=24 months for POLARMAP™ Circular Mapping Catheter and POLARMAP™ EP Electrical Cable
- . Design validation testing summary demonstrating that the POLARSHEATH™ Steerable Sheath 12F and POLARMAP™ Circular Mapping Catheter (including the POLARMAP™ EP Electrical Cable) conform to user needs and intended uses
VIII. CONCLUSION
Based on the intended use, fundamental technological characteristics, and performance testing, the proposed POLARSHEATH™ Steerable Sheath 12F, POLARMAP™ Circular Mapping Catheter, POLARMAP™ EP Electrical Cable, SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cables, and SMARTFREEZE™ Pressure Sensor Cable have been shown to be substantially equivalent to their respective predicate devices.
§ 870.1280 Steerable catheter.
(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).